Influenza virus vaccine (Injection)

Introduction

Influenza Virus Vaccine (Subvirion) (in-floo-EN-za VYE-rus VAX-een (sub-VEER-ee-on))

Keeps you from getting sick with an influenza virus ("catching the flu").

Brand Name(s)

Fluarix, Fluzone, Fluvirin, Flulaval, Afluria, Fluzone High-Dose

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not receive this vaccine if you have had an allergic reaction to influenza vaccine (flu shot). If you have an allergy to kanamycin, neomycin, or polymyxin, you can only receive certain brands of this vaccine. Make sure your health caregiver knows if you are allergic to eggs or chicken, because in most cases you should not receive this vaccine. Tell your doctor if you have a history of problems with your nervous system because in some cases you should not receive this vaccine. If you are very sick and have a high fever, you will probably need to wait until you are well before your receive this vaccine. This vaccine is not recommended for babies younger than 6 months of age.

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose. This medicine is given as a shot into one of your muscles or into your skin, usually in the shoulder area.
• A nurse or other trained health professional will give you this medicine.
• Sometimes there is not enough flu vaccine for everyone. If this happens and you are a healthy adult, you might need to wait until later in the flu season before getting your vaccination.
• There are special instructions for a child who is younger than 9 years of age and who has not had a flu shot before. This child may need to be given two shots. The second shot should be given about one month after the first shot. It is usually best for the child to have received both shots before December.
• You need to get the flu vaccine every year to protect you from the flu.

If a dose is missed:

• Most people need only one dose of this medicine.
• If your child needs a second dose of this medicine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment, make another appointment as soon as possible.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using a medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. Your doctor may still want you to get the vaccine because it can give you some protection.
• Tell your doctor if you are also using a blood thinner (such as warfarin, Coumadin®), phenytoin (Dilantin®), or theophylline (Theo-Dur®).

Warnings While Using This Medicine

• Make sure your doctor or the person who gives the injection knows if you are pregnant or breastfeeding. A woman who is pregnant or breastfeeding can often still receive the flu vaccine. Many times pregnant women and mothers of young children are encouraged to get a flu shot.
• It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving Fluzone® Intradermal vaccine.
• Make sure your doctor or the person who gives the injection knows if you or your child have HIV or AIDS, cancer, or any problems with your immune system.
• Make sure your doctor knows if you or your child have had Guillain-Barré syndrome (GBS, a severe nerve and muscle problem). Tell your doctor if you or your child have bleeding problems (such as hemophilia) or have ever had an unusual reaction to a flu shot, such as severe muscle weakness.
• Children who have received a certain brand of the influenza vaccine (Afluria®) have developed a fever and in some cases a fever with seizures. Talk with your doctor if you have concerns about this.
• This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or troubled breathing after you get the injection.
• Your protection from the flu takes about two weeks to develop.
• The tip cap of the prefilled syringe of certain brands of the injection contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you receive this vaccine.
• Influenza virus vaccine may not protect everyone who receives the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever over 103 degrees F.
• Seizures.
• Severe muscle pain or weakness.
• Shortness of breath or wheezing.

If you notice these less serious side effects, talk with your doctor:

• Back pain.
• Diarrhea or vomiting.
• Drowsiness.
• Headache.
• Irritability or crying.
• Loss of appetite.
• Mild fever, cough, runny or stuffy nose, sore throat, tiredness, muscle or joint pain, or rash (should go away after two days).
• Redness, pain, swelling, soreness, or a small lump where the shot was given (should go away after two days).

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088